(186 days)
Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of SS-A (Ro) (52 kD and 60 kD) Ig G antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and Sjögren's Syndrome in conjunction with clinical findings and other laboratory tests.
Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of SS-B (La) IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and Sjögren's Syndrome in conjunction with clinical findings and other laboratory tests.
Enzyme linked immunoassay (ELISA) for the qualitative detection of Sm IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with clinical findings and other laboratory tests.
Enzyme linked immunoassay (ELISA) for the qualitative and semi-quantitative detection of RNP IgG antibodies in human serum as an aid in diagnosis of Systemic Lupus Erythematosus (SLE) and Mixed Connective Tissue Disease (MCTD) in conjunction with clinical findings and other laboratory tests.
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I am sorry, but the provided text from the FDA 510(k) summary only contains the indications for use for several ImmuLisa Enhanced™ antibody ELISA tests.
It does not include information about:
- Acceptance criteria for device performance.
- The study design, sample sizes (training or test sets), data provenance, number or qualifications of experts, adjudication methods, or ground truth establishment.
- Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone performance study.
Therefore, I cannot fulfill your request for this specific document.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).